United States HPV Testing Market Overview

The United States Human Papilloma Virus (HPV) Testing Market is expected to grow significantly, reaching USD 1,013.55 million by 2033 from USD 457.52 million in 2024, at a CAGR of 9.24% between 2025 and 2033. The market’s growth is fueled by increasing awareness of cervical cancer prevention, broader adoption of screening programs, technical advancements, and the rising utilization of sophisticated diagnostic technologies in healthcare settings.

The market report provides an in-depth analysis of the U.S. HPV testing industry, including segmentation by application, product, distribution channels, end use, and states, as well as company insights for leading players like Abbott Laboratories, Bio-Rad Laboratories, Roche, Siemens Healthineers, and Hologic.

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United States HPV Testing Market Outlook

The American Cancer Society (ACS) and the U.S. Preventive Services Task Force (USPSTF) strongly recommend primary HPV testing or co-testing for women aged 30–65. This has driven adoption across the country, supported by FDA-approved high-sensitivity, genotype-specific HPV assays, such as Abbott’s Alinity m HR HPV assay (Nov 2023) and Roche’s cobas HPV Test.

Efforts to improve screening access for underserved populations are increasing through self-sampling initiatives led by organizations like Kaiser Permanente. Public awareness campaigns from the CDC and the American Sexual Health Association further support these initiatives. These programs align with U.S. government objectives to reduce cervical cancer incidence, thereby fostering demand for HPV testing.

Updated clinical guidelines, regulatory approvals, and patient-centered approaches have accelerated the adoption of HPV testing. In July 2020, the ACS recommended primary HPV testing every five years for individuals aged 25–65, citing superior accuracy, extended screening intervals, and fewer unnecessary procedures compared with traditional Pap smears. The ACS emphasized that HPV testing reduces overdiagnosis and more accurately identifies high-grade precancerous lesions.

Similarly, the USPSTF (December 2024) recommends HPV testing every five years for women aged 30–65, with Pap or co-testing as acceptable alternatives. For the first time, self-collected HPV samples in clinical settings were acknowledged as accurate and effective for improving uptake among historically under screened groups.

With 13,000 new cervical cancer cases and 4,000 related deaths annually in the U.S., over half occurring in underserved populations, HPV testing programs targeting these gaps are crucial. Initiatives like the National Cancer Institute's Cervical Cancer "Last Mile" Initiative are aligned with WHO’s 2030 cervical cancer elimination goals. Growing adoption of self-collection, high-sensitivity molecular assays, and reimbursement coverage is expected to propel the U.S. HPV testing market in the coming years.

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Key Market Growth Drivers

1. Rising Awareness and Preventive Healthcare Initiatives

Public health campaigns, education programs, and outreach initiatives are expanding HPV testing adoption across the U.S. Government agencies and NGOs actively promote cervical cancer prevention through regular screening. Emphasis on early detection encourages women to undergo routine HPV testing.

These campaigns are especially effective in urban centers where healthcare access is strong, but efforts are also expanding to underserved populations. Integration of HPV testing into national prevention guidelines has strengthened its role as a primary diagnostic tool, resulting in increased participation and reinforcing market growth.

2. Technological Advancements in Diagnostic Tools

Rapid advancements in diagnostic technology are improving HPV test accuracy, turnaround times, and scalability. Adoption of molecular assays, PCR-based methods, automation, and AI-supported diagnostic platforms enables precise identification of high-risk HPV strains and supports integration into broader diagnostic panels.

Next-generation sequencing (NGS) technologies allow clinicians to assess patient risk profiles more comprehensively. Technological progress reduces operational complexity, increases reliability, and broadens access to HPV testing across clinical and non-clinical healthcare settings, serving as a key driver of market expansion.

3. Growing Healthcare Investments and Screening Programs

Rising healthcare expenditure and expanded insurance coverage have increased access to HPV testing. Government and private programs ensure wider adoption across demographics, with funding support for low-income and rural populations helping to bridge healthcare gaps.

Insurance coverage for HPV testing lowers out-of-pocket costs and encourages participation. Healthcare systems are investing in infrastructure, advanced testing equipment, and workforce training to support molecular diagnostics. This focus on preventive medicine ensures HPV testing remains a priority within the U.S. healthcare framework.

Market Challenges

1. Socioeconomic and Accessibility Barriers

Disparities in healthcare access persist, particularly for rural and low-income populations. Lack of awareness, cultural stigma, and language barriers reduce screening participation. Limited infrastructure and outreach further hinder access.

Addressing these challenges requires community-based programs, mobile testing units, targeted awareness campaigns, and policy reforms to ensure equitable access across all demographic groups, thereby maximizing the market potential.

2. High Costs and Implementation Challenges

Advanced HPV testing technologies, including molecular assays, DNA sequencing, and automated platforms, often come with significant costs. While large hospitals can absorb these expenses, smaller clinics and uninsured patients face financial barriers.

Implementation hurdles include the need for specialized equipment, trained personnel, and regulatory compliance. Though insurance coverage is improving, reimbursement gaps remain. Achieving widespread, cost-effective adoption is crucial to ensure consistent HPV testing utilization nationwide.

U.S. HPV Testing Market by States

Adoption varies by region, with strong demand in California, Texas, New York, and Florida, driven by healthcare infrastructure, awareness initiatives, and government-supported programs.

California

California has one of the largest HPV testing markets, supported by robust healthcare infrastructure and diverse populations. Government programs and community health initiatives promote cervical cancer screening, while molecular diagnostic technologies in hospitals enhance testing accuracy. Outreach programs target underserved communities, making California a key driver of national market growth.

Texas

Texas has a significant HPV testing market, supported by urban centers such as Houston, Dallas, and Austin, which exhibit strong adoption due to advanced healthcare infrastructure. Mobile screening units and state-supported initiatives aim to improve access in rural areas. Molecular diagnostics are increasingly integrated into hospitals and labs, supporting the preventive healthcare agenda.

New York

New York leads in HPV testing adoption due to strong healthcare infrastructure, research institutions, and public health programs. Urban centers, especially New York City, provide extensive access to advanced diagnostic technologies. Outreach programs target minority and underserved populations, and insurance coverage supports broad utilization.

Florida

Florida exhibits strong market adoption due to preventive care focus and a large, diverse population. Urban areas like Miami, Orlando, and Tampa benefit from advanced diagnostics, while rural regions face access challenges. Partnerships with non-profits and adoption of molecular testing technologies further support market growth.

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Recent Developments

In April 2025, Quest Diagnostics launched a new program to expand self-collected HPV screening for women at risk of cervical cancer. Available at 2,000 patient service locations, the program allows patients to collect samples in clinical settings under physician guidance, leveraging Roche’s FDA-approved Cobas HPV self-collection method. This initiative builds on Quest’s earlier self-collection services for vaginitis and sexually transmitted infections launched in October 2024. The program enhances accessibility, convenience, and privacy while maintaining clinical accuracy.

Market Segmentation

By Application:

·        Cervical Cancer Screening

·        Vaginal Cancer Screening

By Product:

·        Consumables

·        Instruments

·        Services

By Distribution Channels:

·        Polymerase Chain Reaction (PCR)

·        Liquid-Based Cytology

·        Immunodiagnostics

·        Hybrid Capture

·        Others

By End Use:

·        Hospitals & Clinics

·        Laboratories

·        Others

By States:
California, Texas, New York, Florida, Illinois, Pennsylvania, Ohio, Georgia, New Jersey, Washington, North Carolina, Massachusetts, Virginia, Michigan, Maryland, Colorado, Tennessee, Indiana, Arizona, Minnesota, Wisconsin, Missouri, Connecticut, South Carolina, Oregon, Louisiana, Alabama, Kentucky, and Rest of United States.

Competitive Landscape

The U.S. HPV testing market is highly competitive, with key players focusing on product innovation, technological integration, regulatory compliance, and strategic partnerships. Companies are evaluated based on overview, key personnel, recent developments, SWOT analysis, and revenue performance.

Leading Companies Include:

·        Abbott Laboratories

·        BioMerieux SA

·        Bio-Rad Laboratories, Inc.

·        Epigenomics AG

·        Siemens Healthineers AG

·        Hologic Inc.

·        Qiagen NV

·        F. Hoffmann-La Roche Ltd

These players are leveraging molecular assays, automation, self-collection kits, and next-generation sequencing to strengthen market presence and drive adoption in hospitals, clinics, and laboratories.

Conclusion

The U.S. HPV testing market is poised for robust growth from 2025 to 2033, driven by rising awareness, preventive healthcare initiatives, technological innovation, and increased healthcare investments. Self-collection programs, high-sensitivity molecular assays, and insurance coverage expansion are key growth enablers.

Despite challenges such as socioeconomic disparities, access barriers, and high testing costs, targeted outreach, mobile screening programs, and public-private collaborations are expected to broaden adoption nationwide. With continued investment in advanced diagnostics and preventive care programs, HPV testing will play a pivotal role in reducing cervical and vaginal cancer incidence in the United States.

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